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Rifaximin for the Secondary Prevention of Recurrent Pouchitis

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jul 2026 → Jul 2027
See other at-risk trials from University of North Carolina, Chapel Hill

Record History

  1. Primary and study completion pushed from Jul 2026 to Jul 2027 Collaborators: 1 to 2v6 Show 1 more changeShow less
    • Collaborators: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 1 to 2v5
  3. Enrollment target: 8 to 16v4
  4. Trial status: Not Yet Recruiting to Recruiting Primary and study completion dates: Apr 2026 to Jul 2026 · Start date changed from estimate of Apr 2024 to Jul 1, 2024 · Site details revisedv3 Show 3 more changesShow less
    • Primary and study completion dates: Apr 2026 to Jul 2026
    • Start date changed from estimate of Apr 2024 to Jul 1, 2024
    • Site details revised
  5. Re-verified, no change to tracked fieldsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Although many people will develop recurrent pouchitis (inflammation of the ileal pouch-anal anastomosis or J-pouch after colectomy for ulcerative colitis) after an initial episode of pouchitis, there are currently no effective treatments to prevent recurrent pouchitis. The goal of this study is to evaluate the potential for rifaximin, an antibiotic, to prevent recurrent pouchitis after treatment for an initial episode of pouchitis. In this study, all patients will be given daily rifaximin for one year after being treated for an initial episode of pouchitis. This study will examine whether people are willing to take rifaximin for one year with the goal of preventing recurrent pouchitis. Additionally, this study will examine whether patients experience any unexpected side effects of rifaximin therapy. The information gained through this study will potentially be helpful in improving the ability to prevent recurrent pouchitis in patients who have a colectomy for ulcerative colitis.
Trial Details
NCT Number NCT06312683
Lead Sponsor University of North Carolina, Chapel Hill
Collaborators: Bausch Health Americas, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Pouchitis
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov